Insights on Health Care
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ArentFox Schiff is pleased to announce that 23 practices and 81 attorneys have been recognized by The Legal 500 United States 2026 guide.
Headlines that Matter for Companies and Executives in Regulated Industries
On June 2, the US Food and Drug Administration (FDA) released a new draft guidance called “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.”
On June 8, the California State Senate adopted Senate Resolution (SR) 104, a measure expressing support for targeting the biological mechanisms of aging as a strategy to prevent and delay chronic disease.
The 2027 DC budget proposes substantial investments in health care access, behavioral health services, and public health infrastructure across the District of Columbia. Nearly four in 10 DC residents depend on Medicaid, the Basic Health Plan, or the locally funded Alliance program for coverage.
On June 4, the US Supreme Court issued a unanimous decision authored by Justice Ketanji Brown Jackson in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24–889, delivering a significant win for generic pharmaceutical manufacturers seeking US Food and Drug Administration (FDA) approval for drugs with multiple indications.
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The US Departments of Treasury, Labor, and Health and Human Services have issued a sweeping final rule (CMS-9897-F) implementing significant changes to the Federal Independent Dispute Resolution (IDR) process established under the No Surprises Act (NSA).
ArentFox Schiff is pleased to announce that 68 attorneys were recognized as leaders in their field and 25 practices spanning the firm’s litigation, regulatory, and transactional capabilities, as well as key industries, were ranked among the best in the country in the 2026 edition of Chambers USA: America’s Leading Lawyers for Business.
Forget science fiction — the race to connect computers directly to the human brain is already underway, and it is accelerating. In recent months, neurotechnology companies have expanded human clinical trials and attracted substantial investment.
In a 2-1 decision authored by Judge Timothy B. Dyk, the Federal Circuit reversed a jury verdict awarding Insulet Corporation over $59 million in compensatory and exemplary damages for trade secret misappropriation under the Defend Trade Secrets Act (DTSA).
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ArentFox Schiff’s Gayland Hethcoat on navigating the line between wellness and medical devices in the longevity era.
On April 29, the US Food and Drug Administration (FDA) published a Request for Information (RFI) seeking public comment on a proposed pilot program to test the use of artificial intelligence (AI) in early-stage clinical trials for drugs and biologics. Comments are due June 29.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
On May 13, the Centers for Medicare & Medicaid Services (CMS) implemented two separate nationwide moratoria that halt the Medicare enrollment of new home health agencies (HHAs) and hospice providers. The moratoria took effect immediately.
Mail and telemedicine access to mifepristone — used together with misoprostol to end an early pregnancy — is in flux following a Fifth Circuit Court of Appeals ruling that restricts mail-order distribution of the medication nationwide, and the US Supreme Court’s subsequent administrative stay restoring the status quo ante on a temporary basis.
On May 1, the US Food and Drug Administration (FDA) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. If finalized, this proposal would close the last remaining regulatory pathway for large-scale compounding of these popular GLP-1 receptor agonists by 503B outsourcing facilities.
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Michelle J. Shapiro will speak on the “Health Care Fraud Enforcement: Examining the Current Era” panel at the Boston Bar Association’s (BBA) 2026 White-Collar Crime Conference.
False Claims Act Investigations & Litigation attorneys Jacques Smith, Pat Naples, and John Keblish authored a piece for Chief Healthcare Executive on the key regulatory developments and emerging areas of risk in cybersecurity-specific False Claims Act (FCA) settlements.
Headlines that Matter for Companies and Executives in Regulated Industries
Everyone is talking about peptides. Your doctor, your trainer, that guy at the dinner party who swears that BPC-157 rebuilt his knee — peptides have officially entered the zeitgeist. But for every breathless testimonial, there is a thicket of regulations that most market participants barely understand.
On April 18, President Trump signed an executive order (EO) directing multiple federal agencies to accelerate research and expand access to psychedelic drugs as potential treatments for serious mental health conditions. The EO represents a notable shift in federal policy toward psychedelic substances and their potential therapeutic use.